Anti-proliferative combination therapy comprising satraplatin or jm118 and a taxane

Abstract

The present invention describes a method of prevention and/or treatment of a cancer or a tumor, and in particular a combination therapy, methods, compositions and pharmaceutical packages comprising a taxane and certain platinum-based chemotherapeutic agents.

1 . A packaged pharmaceutical, comprising a first pharmaceutical composition comprising either:
 (i) a compound having the structure of   
     
       
         
         
             
             
         
       
       
         
         
             
             
         
       
       (ii) docetaxel, 
       wherein said packaged pharmaceutical further comprises instructions to administer, to an individual suffering from a cancer or a tumor, said first pharmaceutical composition and a second pharmaceutical composition within about 14 days of each other, said second pharmaceutical composition comprising: 
       (a) in the case of (i), a taxane, or, 
       (b) in the case of (ii), a compound as described in (i). 
     
   
   
       2 . (canceled) 
   
   
       3 . A method of treatment of an individual suffering from a cancer or a tumor, the method comprising administering to the individual a first pharmaceutical composition and a second pharmaceutical composition, wherein said first pharmaceutical composition comprising either:
 (i) a compound having the structure of   
     
       
         
         
             
             
         
       
       
         
         
             
             
         
       
       (ii) docetaxel, 
       wherein said second pharmaceutical composition comprising: 
       (a) in the case of (i), a taxane, or, 
       (b) in the case of (ii), a compound of formula IA or Formula II, 
       wherein said first pharmaceutical composition is administered within about 14 days of administration of the second pharmaceutical composition. 
     
   
   
       4 . (canceled) 
   
   
       5 . A kit for administering a first and a second pharmaceutical composition to an individual suffering from a cancer or a tumor, wherein said kit includes a plurality of separate containers, the contents of at least two containers differing from each other in whole or in part, wherein at least one of such containers contains a taxane, with or without additional pharmaceutical carrier or diluent, and at least one different container contains a compound of Formula IA or Formula II, with or without additional pharmaceutical carrier or diluent. 
   
   
       6 . The kit of  claim 5 , wherein the container containing the taxane does not contain a compound of Formula IA or Formula II, and/or wherein the container containing the compound of Formula IA or Formula II does not contain docetaxel. 
   
   
       7 . (canceled) 
   
   
       8 . The method of  claim 3 , wherein said administration:
 (i) is the sequential administration to said individual of the taxane and the compound of Formula IA or Formula II within about 14 days of each other; or   (ii) results in the sequential contact of a cell included in, derived from or being part of said cancer or tumor with the taxane and the compound of Formula IA or Formula II within about 14 days of each other.   
   
   
       9 . The method of  claim 3 , wherein said administration:
 (i) is the sequential administration to said individual of first the taxane and then the compound of Formula IA or Formula II within about 14 days of each other;   (ii) results in the sequential contact of a cell included in, derived from or being part of said cancer or tumor with first the taxane and then the compound of Formula IA or Formula II within about 14 days of each other;   (iii) is the sequential administration to said individual of first the compound of Formula IA or Formula II and then the taxane within about 14 days of each other; or   (iv) results in the sequential contact of a cell included in, derived from or being part of said cancer or tumor with first the compound of Formula IA or Formula II and then the taxane within about 14 days of each other.   
   
   
       10 . The method of  claim 3 , wherein said administration:
 (i) is the sequential administration to said individual of the taxane and the compound of Formula IA or Formula II within about 10 days, 7 days, 5 days, 3 days, 2 days or 1 day of each other; or   (ii) results in the sequential contact of a cell included in, derived from or being part of said cancer or tumour with the taxane and the compound of Formula IA or Formula II within about 10 days, 7 days, 5 days, 3 days, 2 days or 1 day of each other.   
   
   
       11 . The method of  claim 3 , wherein said administration:
 (i) is the sequential administration to said individual of the taxane and the compound of Formula IA or Formula II within about 48 hours, 24 hours, 12 hours, 8 hours, 6 hours, 4 hours, 2 hours, 1 hour, 30 mins, 15 mins or 5 mins of each other; or   (ii) results in the sequential contact of a cell included in, derived from or being part of said cancer or tumour with the taxane and the compound of Formula IA or Formula II within about 48 hours, 24 hours, 12 hours, 8 hours, 6 hours, 4 hours, 2 hours, 1 hour, 30 mins, 15 mins or 5 mins of each other.   
   
   
       12 . The method of  claim 3 , wherein the first and second pharmaceutical compositions are administered to said individual effectively at the same time. 
   
   
       13 . The method of  claim 3 , wherein said cancer or said tumor is included in, derived from or is a solid tumor. 
   
   
       14 . The method of  claim 13 , wherein said solid tumor is selected from: breast cancer, cervical cancer, colorectal cancer, peritoneal cancer, ovarian cancer, bronchial cancer, small cell lung cancer, non-small cell lung cancer, gastric, head and neck cancer, or metastases thereof. 
   
   
       15 . The method  13 , wherein said solid tumor is prostate cancer. 
   
   
       16 . The method of  claim 3 , wherein said cancer or said tumor is included in, derived from or is a hematological tumor. 
   
   
       17 . The method of  claim 15 , wherein said prostate cancer is hormone-refractory prostate cancer. 
   
   
       18 . The method of  claim 3 , wherein said cancer or said tumor is a tumor or a cancer resistant or refractory to an antiproliferative agent. 
   
   
       19 . The method of  claim 18 , wherein said antiproliferative agent is cisplatin. 
   
   
       20 . The method of  claim 18 , wherein said antiproliferative agent is not a hormone-based drug. 
   
   
       21 - 26 . (canceled) 
   
   
       27 . The method of  claim 3 , wherein said taxane is docetaxel or paclitaxel. 
   
   
       28 - 37 . (canceled) 
   
   
       38 . A method for killing or inhibiting the growth of a tumor cell comprising contacting said cell with an effective amount of (a) a taxane, and (b) a platinum-based chemotherapeutic agent selected from a compound having the structure of Formula IA or Formula II. 
   
   
       39 . The method of  claim 38 , wherein said cell is a proliferating cell comprised in or derived from a tumor. 
   
   
       40 . The method of  claim 39 , wherein said tumor is contained in an individual suffering from a cancer or a tumor. 
   
   
       41 . (canceled) 
   
   
       42 . The method of  claim 38 , wherein the platinum-based chemotherapeutic agent is satraplatin (Formula IA). 
   
   
       43 . The method of  claim 38 , wherein said taxane is docetaxel or paclitaxel. 
   
   
       44 . (canceled) 
   
   
       45 . The method of  claim 38 , wherein satraplatin (Formula IA) or JM118 (Formula II) is contacted with said cell first. 
   
   
       46 . The method of  claim 38 , wherein said taxane is contacted with said cell first.